Ketorolac Tromethamine - Ketorolac Tromethamine tablet prescribing information
WARNING
Ketorolac tromethamine tablets, a nonsteroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine should not exceed 5 days.
Ketorolac tromethamine tablets are not indicated for use in pediatric patients and they are NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events.
GASTROINTESTINAL RISK
- Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ).
CARDIOVASCULAR THROMBOTIC EVENTS
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ).
- Ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ).
RENAL RISK
- Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS ).
RISK OF BLEEDING
- Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ).
Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.
RISK DURING LABOR AND DELIVERY
- The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions.
CONCOMITANT USE WITH NSAIDs
- Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
SPECIAL POPULATIONS
- Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION ) and for patients with moderately elevated serum creatinine (see WARNINGS ).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS , PRECAUTIONS , DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days.
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day
Patients age ≥65, renally impaired, and/or weight <50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions
Patient Population | Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) |
Age < 17 years | Oral not approved |
Adult Age 17 to 64 years | 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day |
Adult Age ≥ 65 years, renally impaired and/or weight <50 kg | 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day |
CONTRAINDICATIONS
(see also BOXED WARNING )
Ketorolac tromethamine tablets are contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.
Ketorolac tromethamine tablets are contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.
Ketorolac tromethamine tablets should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma ).
Ketorolac tromethamine tablets are contraindicated as prophylactic analgesic before any major surgery.
Ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion).
Ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ).
Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.
The concomitant use of ketorolac tromethamine and probenecid is contraindicated.
The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.
ADVERSE REACTIONS
Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see BOXED WARNING , WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.
In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
Gastrointestinal (GI) experiences including: | ||
Abdominal Pain• | Constipation/Diarrhea | Dyspepsia• |
Flatulence | GI Fullness | GI Ulcers (gastric/duodenal) |
Gross Bleeding/Perforation | Heartburn | Nausea• |
Stomatitis | Vomiting | |
Other experiences: | ||
Abnormal Renal Function | Anemia | Dizziness |
Drowsiness | Edema | Elevated Liver Enzymes |
Headaches• | Hypertension | Increased Bleeding Time |
Injection Site Pain | Pruritus | Purpura |
Rashes | Tinnitus | Sweating |
•Incidence greater than 10% | ||
Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include:
Body as a Whole: fever, infections, sepsis
Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope
Dermatologic: alopecia, photosensitivity, urticaria
Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding
Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia
Metabolic and Nutritional: weight change
Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise
Reproductive, female: infertility
Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis
Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss
Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention
Other rarely observed reactions (reported from post-marketing experience in patients taking ketorolac tromethamine or other NSAIDs) are:
Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema (see WARNINGS ), myalgia
Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis
Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell’s syndrome, bullous reactions including Stevens-Johnson Syndrome, and toxic epidermal necrolysis, and fixed drug eruption (FDE)
Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, postoperative wound hemorrhage (rarely requiring blood transfusion - see BOXED WARNING , WARNINGS , and PRECAUTIONS )
Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia
Nervous System: aseptic meningitis, convulsions, coma, psychosis
Respiratory: bronchospasm, respiratory depression, pneumonia
Special Senses: conjunctivitis
Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome
Post-Marketing Surveillance Study: A large post-marketing observational, nonrandomized study, involving approximately 10,000 patients receiving ketorolac tromethamine IV or IM, demonstrated that the risk of clinically serious gastrointestinal (G.I.) bleeding was dose dependent (see Tables 3A and 3B). This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamine IV or IM (see Table 3A).
TABLE 3: Incidence of Clinically Serious G.I. Bleeding as Related to Age, Total Daily Dose and History of G.I. Perforation, Ulcer, Bleeding (PUB) after up to 5 Days of Treatment with Ketorolac Tromethamine IV/IM
A. Adult Patients without History of PUB | ||||
Age of Patients | Total Daily Dose of Ketorolac Tromethamine IV/IM | |||
≤ 60 mg | > 60 to 90 mg | > 90 to 120 mg | > 120 mg | |
< 65 years of age | 0.4% | 0.4% | 0.9% | 4.6% |
≥ 65 years of age | 1.2% | 2.8% | 2.2% | 7.7% |
B. Adult Patients with History of PUB | ||||
Age of Patients | Total Daily Dose of Ketorolac Tromethamine IV/IM | |||
≤ 60 mg | > 60 to 90 mg | > 90 to 120 mg | > 120 mg | |
< 65 years of age | 2.1% | 4.6% | 7.8% | 15.4% |
≥ 65 years of age | 4.7% | 3.7% | 2.8% | 25% |
DESCRIPTION
Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-Benzoyl-2,3-dihydro-1 H - pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is:
C 15 H 13 NO 3 • C 4 H 11 NO 3
Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41.
Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80.
FDA approved dissolution specifications differ from USP.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The biological activity of ketorolac tromethamine is associated with the S-form. Ketorolac tromethamine possesses no sedative or anxiolytic properties.
The peak analgesic effect of ketorolac tromethamine occurs within 2 to 3 hours and is not statistically significantly different over the recommended dosage range of ketorolac tromethamine. The greatest difference between large and small doses of ketorolac tromethamine is in the duration of analgesia.
Pharmacokinetics
Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S-form having analgesic activity.
Comparison of IV, IM and Oral Pharmacokinetics
The pharmacokinetics of ketorolac tromethamine, following IV, IM and oral doses of ketorolac tromethamine tablets, are compared in Table 1. In adults, the extent of bioavailability following administration of the oral and IM forms of ketorolac tromethamine was equal to that following an IV bolus.
Linear Kinetics
In adults, following administration of single oral, IM or IV doses of ketorolac tromethamine in the recommended dosage ranges, the clearance of the racemate does not change. This implies that the pharmacokinetics of ketorolac tromethamine in adults, following single or multiple IM, IV or recommended oral doses of ketorolac tromethamine, are linear. At the higher recommended doses, there is a proportional increase in the concentrations of free and bound racemate.
Absorption
Ketorolac tromethamine is 100% absorbed after oral administration (see Table 1). Oral administration of ketorolac tromethamine after a high-fat meal resulted in decreased peak and delayed time-to-peak concentrations of ketorolac tromethamine by about 1hour. Antacids did not affect the extent of absorption.
Distribution
The mean apparent volume (V β ) of ketorolac tromethamine following complete distribution was approximately 13 liters. This parameter was determined from single-dose data. The ketorolac tromethamine racemate has been shown to be highly protein bound (99%). Nevertheless, plasma concentrations as high as 10 mcg/mL will only occupy approximately 5% of the albumin binding sites. Thus, the unbound fraction for each enantiomer will be constant over the therapeutic range. A decrease in serum albumin, however, will result in increased free drug concentrations.
Ketorolac tromethamine is excreted in human milk (see PRECAUTIONS: Nursing Mothers ).
Metabolism
Ketorolac tromethamine is largely metabolized in the liver. The metabolic products are hydroxylated and conjugated forms of the parent drug. The products of metabolism, and some unchanged drug, are excreted in the urine.
Excretion
The principal route of elimination of ketorolac and its metabolites is renal. About 92% of a given dose is found in the urine, approximately 40% as metabolites and 60% as unchanged ketorolac.
Approximately 6% of a dose is excreted in the feces. A single-dose study with 10 mg ketorolac tromethamine (n = 9) demonstrated that the S-enantiomer is cleared approximately 2 times faster than the R-enantiomer and that the clearance was independent of the route of administration. This means that the ratio of S/R plasma concentrations decreases with time after each dose. There is little or no inversion of the R- to S- form in humans. The clearance of the racemate in normal subjects, elderly individuals and in hepatically and renally impaired patients is outlined in Table 2 (see CLINICAL PHARMACOLOGY: Kinetics in Special Populations ).
The half-life of the ketorolac tromethamine S-enantiomer was approximately 2.5 hours (SD ± 0.4) compared with 5 hours (SD ± 1.7) for the R-enantiomer. In other studies, the half-life for the racemate has been reported to lie within the range of 5 to 6 hours.
Accumulation
Ketorolac tromethamine administered as an IV bolus every 6 hours for 5 days to healthy subjects (n = 13), showed no significant difference in C max on Day 1 and Day 5. Trough levels averaged 0.29 mcg/mL (SD ± 0.13) on Day 1 and 0.55 mcg/mL (SD ± 0.23) on Day 6. Steady-state was approached after the fourth dose.
Accumulation of ketorolac tromethamine has not been studied in special populations (geriatric, pediatric, renal failure or hepatic disease patients).
Kinetics in Special Populations
Geriatric Patients
Based on single-dose data only, the half-life of the ketorolac tromethamine racemate increased from 5 to 7 hours in the elderly (65 to 78 years) compared with young healthy volunteers (24 to 35 years) (see Table 2). There was little difference in the C max for the two groups (elderly, 2.52 mcg/mL ± 0.77; young, 2.99 mcg/mL ± 1.03) (see PRECAUTIONS: Geriatric Use ).
Pediatric Patients
Limited information is available regarding the pharmacokinetics of dosing of ketorolac tromethamine in the pediatric population. Following a single intravenous bolus dose of 0.5 mg/kg in 10 children 4 to 8 years old, the half-life was 5.8 ± 1.6 hours, the average clearance was 0.042 ± 0.01 L/hr/kg, the volume of distribution during the terminal phase (V β ) was 0.34 ± 0.12 L/kg and the volume of distribution at steady state (V ss ) was 0.26 ± 0.08 L/kg. The volume of distribution and clearance of ketorolac in pediatric patients was higher than those observed in adult subjects (see Table 1). There are no pharmacokinetic data available for administration of ketorolac tromethamine by the IM route in pediatric patients.
Renal Insufficiency
Based on single-dose data only, the mean half-life of ketorolac tromethamine in renally impaired patients is between 6 and 19 hours and is dependent on the extent of the impairment. There is poor correlation between creatinine clearance and total ketorolac tromethamine clearance in the elderly and populations with renal impairment (r = 0.5).
In patients with renal disease, the AUC ∞ of each enantiomer increased by approximately 100% compared with healthy volunteers. The volume of distribution doubles for the S-enantiomer and increases by 1/5th for the R-enantiomer. The increase in volume of distribution of ketorolac tromethamine implies an increase in unbound fraction.
The AUC ∞ -ratio of the ketorolac tromethamine enantiomers in healthy subjects and patients remained similar, indicating there was no selective excretion of either enantiomer in patients compared to healthy subjects (see WARNINGS: Renal Effects ).
Hepatic Insufficiency
There was no significant difference in estimates of half-life, AUC ∞ and C max in 7 patients with liver disease compared to healthy volunteers (see PRECAUTIONS: General: Hepatic Effect and Table 2).
Race
Pharmacokinetic differences due to race have not been identified.
TABLE 1: Table of Approximate Average Pharmacokinetic Parameters (Mean ±SD) Following Oral, Intramuscular and Intravenous Doses of Ketorolac Tromethamine
Pharmacokinetic Parameters (units) | Oral • | Intramuscular † | Intravenous Bolus ‡ | |||
10 mg | 15 mg | 30 mg | 60 mg | 15 mg | 30 mg | |
Bioavailability (extent) | 100% | |||||
T max § (min) | 44 ± 34 | 33 ± 21 ¶ | 44 ± 29 | 33 ± 21 ¶ | 1.1 ± 0.7 ¶ | 2.9 ± 1.8 |
C max # (mcg/mL) [single dose] | 0.87 ± 0.22 | 1.14 ± 0.32 ¶ | 2.42 ± 0.68 | 4.55 ± 1.27 ¶ | 2.47 ± 0.51 ¶ | 4.65 ± 0.96 |
C max (mcg/mL) [steady state q.i.d.] | 1.05 ± 0.26 ¶ | 1.56 ± 0.44 ¶ | 3.11 ± 0.87 ¶ | N/A Þ | 3.09 ± 1.17 ¶ | 6.85 ± 2.61 |
C min ß (mcg/mL) [steady state q.i.d.] | 0.29 ± 0.07 ¶ | 0.47 ± 0.13 ¶ | 0.93 ± 0.26 ¶ | N/A | 0.61 ± 0.21 ¶ | 1.04 ± 0.35 |
C avg à (mcg/mL) [steady state q.i.d.] | 0.59 ± 0.20 ¶ | 0.94 ± 0.29 ¶ | 1.88 ± 0.59 ¶ | N/A | 1.09 ± 0.30 ¶ | 2.17 ± 0.59 |
Vß è (L/kg) | 0.175 ± 0.039 | 0.210 ± 0.044 | ||||
% Dose metabolized = < 50 % Dose excreted in urine = 91 % Dose excreted in feces = 6 % Plasma protein binding = 99
• Derived from PO pharmacokinetic studies in 77 normal fasted volunteers † Derived from IM pharmacokinetic studies in 54 normal volunteers ‡ Derived from IV pharmacokinetic studies in 24 normal volunteers § Time-to-peak plasma concentration ¶ Mean value was simulated from observed plasma concentration data and standard deviation was simulated from percent coefficient of variation for observed C max and T max data. # Peak plasma concentration Þ Not Applicable because 60 mg is only recommended as a single-dose ß Trough plasma concentration à Average plasma concentration è Volume of Distribution
TABLE 2: The Influence of Age, Liver and Kidney Function on the Clearance and Terminal Half-life of Ketorolac Tromethamine (IM • and Oral † ) in Adult Populations
Types of Subjects | Total Clearance [in L/h/kg] ‡ | Terminal Half-Life [in hours] | ||
IM Mean (range) | ORAL Mean (range) | IM Mean (range) | ORAL Mean (range) | |
Normal Subjects | ||||
IM (n = 54) mean age = 32, | 0.023 | 0.025 | 5.3 | 5.3 |
range = 18 to 60 | (0.010 to 0.046) | (0.013 to 0.050) | (3.5 to 9.2) | (2.4 to 9) |
Oral (n = 77) mean age = 32, | ||||
range = 20 to 60 | ||||
Healthy Elderly Subjects | 0.019 | 0.024 | 7 | 6.1 |
IM (n = 13), Oral (n = 12) | (0.013 to 0.034) | (0.018 to 0.034) | (4.7 to 8.6) | (4.3 to 7.6) |
mean age = 72, range = 65 to 78 | ||||
Patients with Hepatic Dysfunction IM and Oral (n = 7) mean age = 51, range = 43 to 64 | 0.029 (0.013 to 0.066) | 0.033 (0.019 to 0.051) | 5.4 (2.2 to 6.9) | 4.5 (1.6 to 7.6) |
Patients with Renal Impairment IM (n = 25), Oral ( n = 9) serum creatinine = 1.9 to 5 mg/dL mean age (IM) = 54, range 35 to 71 mean age (oral) = 57, range = 39 to 70 | 0.015 (0.005 to 0.043) | 0.016 (0.007 to 0.052) | 10.3 (5.9 to 19.2) | 10.8 (3.4 to 18.9) |
Renal Dialysis Patients IM and Oral (n =9), mean age = 40, range = 27 to 63 | 0.016 (0.003 to 0.036) | ―― | 13.6 (8 to 39.1) | ―― |
• Estimated from 30 mg single IM doses of ketorolac tromethamine † Estimated from 10 mg single oral doses of ketorolac tromethamine ‡ Liters/hour/kilogram
IV Administration
In normal adult subjects (n = 37), the total clearance of 30 mg IV administered ketorolac tromethamine was 0.030 (0.017 to 0.051) L/h/kg. The terminal half-life was 5.6 (4 to 7.9) hours. (see Kinetics in Special Populations for use of IV dosing of ketorolac tromethamine in pediatric patients).
CLINICAL STUDIES
Adult Patients
In a postoperative study, where all patients received morphine by a PCA device, patients treated with ketorolac tromethamine-IV as fixed intermittent boluses (e.g., 30 mg initial dose followed by 15 mg q3h), required significantly less morphine (26%) than the placebo group. Analgesia was significantly superior, at various postdosing pain assessment times, in the patients receiving ketorolac tromethamine-IV plus PCA morphine as compared to patients receiving PCA-administered morphine alone.
Pediatric Patients
There are no data available to support the use of ketorolac tromethamine tablets in pediatric patients.
HOW SUPPLIED
Ketorolac Tromethamine Tablets, USP are available containing 10 mg of ketorolac tromethamine, USP. The tablets are white to off-white, film coated round tablets, debossed with “CE” above “203” on one side and plain on the other side. They are available as follows:
NDC 62135-811-60 bottles of 60 tablets with child-resistant closure.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light and excessive humidity.
Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure.
PHARMACIST: Dispense a Medication Guide with each prescription.
Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920
For more information call Chartwell RX, LLC. at 1-845-232-1683.
L72303
Rev. 06/2025
